Biomarkers to Predict Hemorrhage and Outcomes After Endovascular Treatment in Patients With Acute Large Vessel Occlusion

Acute Ischemic Stroke Clinical Trial

Official title:

Biomarkers to Predict Hemorrhage and Outcomes After Endovascular Treatment in Patients With Acute Large Vessel Occlusion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03915834
• Other study ID #: 2018-033
• Status: Not yet recruiting
• Start date: April 16, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2019
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The main aim of the biomarkers to predict Hemorrhagic transformation(HT) after endovascular treatment in Acute Ischemic Stroke Patients.

The study has three main parts. During the first part, the investigators propose to conduct an enrollment of patients after thrombectomy in acute Ischemic Stroke and healthy controls. Serum biomarkers levels were analyzed (before and after) endovascular treatment patients and controls respectively.

During the second part, HT was evaluated and classified on cranial computed tomography and/or MRI post- treatment and was considered as symptomatic HT (sHT) if associated with neurological deterioration.

During the third part, the investigators aim to demonstrate the level of biomarkers can significant predict HT and outcomes in stroke patients undergoing revascularization.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 31, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. be 18 or older;

2. have a clinical diagnosis of acute ischemic stroke

3. a score of 6 or more points on the NIHSS(the National Institutes of Health Stroke Scale);

4. be scheduled to undergo intraarterial (IA) therapy for acute hemispheric stroke;

5. patients eligible for IV alteplase should receive IV alteplase;

6. Intracranial arterial occlusion of the distal intracranial carotid artery, middle (M1/M2) ,anterior (A1/A2) cerebral artery,vertebral artery,basilar artery or posterior cerebral artery,demonstrated with CTA, MRA or DSA;

7. begin intra-arterial therapy within 24 hours of symptom onset;

8. have provided informed consent.

Exclusion Criteria:

1. have any pre-existing illness resulting in a modified Rankin Scale Score of 3 or higher prior to the qualifying stroke;

2. patients with known infectious, inflammatory, or neoplastic diseases at the time of treatment and non-availability of blood samples;

3. are pregnant.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Hemorrhage

Intervention

Device:
• Endovascular treatment
Mechanical thrombectomy and/or Aspiration

Locations

Country	Name	City	State
China	Beijing Luhe Hospital, Capital Medical University	Beijing
China	Xuan Wu Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemorrhagic transformation	Hemorrhagic transformation was diagnosed by Computed tomographic scans usually performed 24 to 72 hours after the procedure.Symptomatic intracranial hemorrhage was defined as neurologic deterioration (an increase of 4 or more points in the score on the NIHSS) and evidence of intracranial hemorrhage on imaging studies.	24 to 72 hours
Secondary	Modified Rankin scale	this scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death).scores of the modified Rankin scale at 2 years (0 or 1 [excel- lent outcome], 0 to 2 [good outcome, indicating functional independence], and 0 to 3 [favorable outcome]).	90 days